Pilot Plant Technician

The Pilot Plant Manufacturing Technician performs end-to-end production of radiopharmaceuticals in strict adherence to current Good Manufacturing Practices and approved Standard Operating Procedures, ensuring quality, sterility, and regulatory compliance at every stage. It prepares, handles, operates, and documents materials and equipment according to validated procedures, maintaining accurate, traceable records and promptly escalating any deviations. The position follows an internal rotation plan with morning and afternoon shifts, requiring flexibility and consistent coordination to meet operational timelines and batch release objectives.
Shift work for preparation, production, and packaging/shipping of sterile radioactive drugs in compliance with HSE, EU GMP Annex 1/3, and applicable regulations
Perform setup, cleaning, and environmental microbiological monitoring (viable and non-viable) of areas and equipment with GMP-based periodic cleaning
Prepare raw materials and batch kits; manage stock and waste per Production Supervisor instructions and HSE SOPs
Complete GMP documentation per ALCOA+ and promptly report deviations/OOS to Production Supervisor, Qualified Person, and HSE Manager
Handle inbound logistics, restock areas, prepare shipping packaging; Manage proper radioactive waste disposal with related records and transport
Support maintenance/qualification, train new personnel, contribute to the site quality system and continuous improvement in line with safety and GMP
Perform technical tests and support process/product qualification and validation; Minimum 2 years in GMP manufacturing support or technical roles, preferably in sterile injectables; Quality and compliance mindset with knowledge of regulatory requirements across multiple health authorities
Proficiency with manufacturing IT systems (e.g., SCADA, HMI) and good office software skills
Language skills: Italian proficient; English desirable
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Manufacturing Process
Materials Science